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Vusion CS Plus

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name
Vusion CS Plus FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Device Name
16 mm x 8 mm x 7 Degree Lordotic FDA UDI
Model / Reference
159-1608-07 FDA UDI
Description
16 mm x 8 mm x 7 Degree Lordotic FDA UDI

Identifiers

Primary DI / UDI-DI
00822409025541 FDA UDI
510(k) Number
K122588 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 7 degree FDA UDI
Width — 16 Millimeter FDA UDI
Height — 8 Millimeter FDA UDI

Vusion CS Plus by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K122588 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA UDI ee54c6e5-fc2a-47cd-a82e-a68e778d2eba 37 fields · synced Jun 1, 2026